ArticleCancer science2021
Real-world safety of nivolumab in patients with non-small-cell lung cancer in Japan: Postmarketing surveillance.
Article in Cancer science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.
- Exploring risk factors for endocrine-related immune-related adverse events: Insights from meta-analysis and Mendelian randomization.Human vaccines & immunotherapeutics · 2024Pooled it
- Adjuvant nivolumab versus placebo following radical surgery for high-risk muscle-invasive urothelial carcinoma: a subgroup analysis of Japanese patients enrolled in the phase 3 CheckMate 274 trial.Japanese journal of clinical oncology · 2023Trial
- A Randomized Comparison of Nivolumab versus Nivolumab + Docetaxel for Previously Treated Advanced or Recurrent ICI-Naïve Non-Small Cell Lung Cancer: TORG1630.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022Trial
- Real-world safety and effectiveness of nivolumab in patients with cancer of unknown primary: results from a nationwide post-marketing surveillance in Japan.International journal of clinical oncology · 2026Observational
- Safety and effectiveness of nivolumab in patients with locally advanced or metastatic non-small cell lung cancer in China: a nationwide electronic health record dataset analysis.Journal of thoracic disease · 2026Article
- Fatal Postoperative Interstitial Lung Disease after Neoadjuvant Nivolumab and Complete Resection for Non-Small Cell Lung Cancer: A Case Report.Surgical case reports · 2026Article
- High incidence of immune checkpoint inhibitor-induced pneumonitis in patients with non-small cell lung cancer and interstitial pneumonia, regardless of honeycomb lung or forced vital capacity: results from a multicenter retrospective study.International journal of clinical oncology · 2025Article
- Prevalence and management of immediate drug hypersensitivity observed during antineoplastic drug therapy.Acta oncologica (Stockholm, Sweden) · 2025Observational
- Signal mining and analysis of influencing factors for adverse events of Nivolumab and Cetuximab in the treatment of head and neck cancer based on the US FAERS database.Frontiers in immunology · 2025Article
- Real-world safety of nivolumab in patients with malignant pleural mesothelioma in Japan: post-marketing surveillance study.Japanese journal of clinical oncology · 2024Article
- Safety of nivolumab monotherapy in five cancer types: pooled analysis of post-marketing surveillance in Japan.International journal of clinical oncology · 2024Article
- Post-marketing surveillance of the safety and effectiveness of nivolumab for classic Hodgkin lymphoma in Japan.International journal of hematology · 2024Observational
- First-line nivolumab plus ipilimumab with or without chemotherapy for Japanese patients with non-small cell lung cancer: LIGHT-NING study.Japanese journal of clinical oncology · 2024Observational
- Endocrine Side Effects in Patients Treated with Immune Checkpoint Inhibitors: A Narrative Review.Journal of clinical medicine · 2023Review
- Common methodological pitfalls in ICI pneumonitis risk prediction studies.Frontiers in immunology · 2023Review
- Real-world outcomes of pembrolizumab monotherapy in non-small cell lung cancer in Japan: A post-marketing surveillance.Cancer science · 2022Article
- Safety and effectiveness of nivolumab in Japanese patients with malignant melanoma: Final analysis of a post-marketing surveillance.The Journal of dermatology · 2022Article
- Impact of treatment line on risks and benefits of immune checkpoint inhibitor in patients with advanced non-small cell lung cancer and interstitial lung disease: a systematic review and meta-analysis of cohort studies.Translational lung cancer research · 2022Article
- Pulmonary adverse events following immune checkpoint inhibitors.Current opinion in pulmonary medicine · 2022Review
- Real-world safety of nivolumab in patients with non-small-cell lung cancer in Japan: Postmarketing surveillance.Cancer science · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 6 institutions in 1 country.
Funding
Abstract
Postmarketing surveillance of Japanese patients with unresectable, previously treated, advanced or recurrent non-small-cell lung cancer treated with nivolumab was undertaken during the conditional approval period. The study aim was to evaluate the occurrence of treatment-related adverse events of nivolumab in the real world. Patients were registered between December 2015 and March 2016 at 536 sites. Nivolumab was given intravenously (3 mg/kg every 2 weeks); the observation period was 12 months after the first dose of nivolumab. Patients were evaluated for safety (n = 3601; 18.2% ≥75 years, 22.4% ECOG performance status ≥2) and effectiveness (n = 3570). The frequencies of any grade and grade 3 or higher treatment-related adverse events were 47.1% and 15.9%, respectively. The most frequent treatment-related adverse events (any grade) were interstitial lung disease (6.4%), hypothyroidism (5.7%), and diarrhea (4.4%). Treatment-related adverse events of special interest (priority items) occurring at a frequency of 5% or more were adverse events related to interstitial lung disease, thyroid dysfunction, liver dysfunction, colitis/severe diarrhea, infusion reaction, and infusion reaction within 24 hours. Significant risk factors for these priority items were identified by competing risk analysis: interstitial lung disease (previous/comorbid interstitial lung disease, abnormal findings on chest imaging, and smoking history); liver dysfunction (previous/comorbid liver disease, smoking history, and metastasis); thyroid dysfunction (previous/comorbid thyroid disease and performance status); and colitis/severe diarrhea (treatment line 2 vs ≥3). The 12-month survival rate was 40.7%. In conclusion, the safety profile of nivolumab in this postmarketing surveillance was similar to that in clinical trials, and no new safety signals were identified. The study was registered with the Japan Pharmaceutical Information Center (clinicaltrials.jp: Japic-163271).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.